Acoustic sensor and ventilation monitoring system

ABSTRACT

A method of monitoring respiration with an acoustic measurement device, the acoustic measurement device having a sound transducer, the sound transducer configured to measure sound associated with airflow through a mammalian trachea, the method includes correlating the measured sound into a measurement of tidal volume and generating at least one from the group consisting of an alert and an alarm if the measured tidal volume falls outside of a predetermined range.

CROSS-REFERENCE TO RELATED APPLICATION

This application is related to and claims priority to U.S. ProvisionalPatent Application Ser. No. 62/857,963, filed Jun. 6, 2019 entitledACOUSTIC SENSOR AND VENTILATION MONITORING SYSTEM, and is also relatedto and claims priority to U.S. Provisional Patent Application Ser. No.62/719,918, filed on Aug. 20, 2018 entitled ACOUSTIC SENSOR SYSTEM, theentirety of which is incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to a method and system for a non-invasivereal-time monitoring system with diagnostic algorithms that continuouslyquantify and analyze the pattern of an ambulatory person's respiratoryrate (RR), tidal volume (TV), degree of upper airway obstruction(talking/snoring), body activity level, body coordination, bodyposition, heart rate, and/or temperature, among other physiologicalconditions.

BACKGROUND

Respiratory rate (RR) is routinely monitored during research studiesusing a tight-fitting band around the wearer's chest or impedancepneumography. In impedance pneumography, a bedside monitormeasures/analyzes the change in electrical impedance across thepatient's thorax during inhalation/exhalation to measure RR accurately.Current respiratory monitors for in-hospital use measure a change inthoracic electrical impedance to measure minute ventilation (RR×TidalVolume (TV)). An array of wearable electrodes is hard-wired to anexpensive bedside monitor/display with threshold and predictive alarmsfor hypoventilation.

Clinicians commonly use a modified nasal oxygen cannula and capnographyin a hospital's ER, OR, ICU, and general floors to continuously monitorrespiratory rate and the exhaled carbon dioxide concentration. The nasalcannulas are cumbersome and easily dislodged from the nose leading to ahigh degree of false alarms. Hospitals also commonly use a pulseoximeter to continuously monitor a patient's hemoglobin oxygensaturation. Unfortunately, a pulse oximeter alarms for arterialhypoxemia only after moderate to severe hypoventilation, especially ifthe hospitalized patient is being managed with supplemental oxygentherapy.

Breathing abnormalities, such as hypoventilation commonly occur as aside effect of central nervous system depressant drugs, for example,opioids, benzodiazepines, barbiturates, etc., with and without alcoholingestion. The human body's ten trillion cells continuously producecarbon dioxide as a waste product of aerobic metabolism. Carbon dioxidemolecules are continuously transported in the flowing blood to thelung's alveoli for excretion into the external environment. The humanbody has a variety of physiological mechanisms for maintaining thepartial pressure of carbon dioxide in arterial blood within a preciserange (PaCO2 40 mm Hg+/−5 mm Hg) by increasing and decreasing the amountof air that moves into and out of the lung's alveoli. Hypoventilation isdefined as an abnormally elevated level of carbon dioxide in thearterial blood (PaCO2>45 mm Hg or respiratory acidosis). This occurswhen the amount of alveolar ventilation does not satisfactorily excretethe amount of CO2 produced by the cells—leading to an elevatedconcentration of CO2 in the arterial bloodstream. Although the impactcaused by hypoventilation is well-recognized, quantitative measurementof ventilation, whether increased or decreased ventilation, has not beenwell established in clinical diagnostics. For example, a nurse on thegeneral ward of a hospital is required to observe a patient's breathingfor a full minute, while counting the number of breaths and estimatingthe depth of breathing. This nursing assessment occurs infrequently andis prone to error. This is in part due to the inability to continuouslyand accurately monitor/measure airflow into and out of the lungs duringambulation in the hospital or real-world environment. The amount of airthat moves into and out of the trachea, bronchi, and alveoli per minuteis called minute ventilation. The amount of air that moves into and outof the alveoli per minute is called alveolar minute ventilation. Theamount of air that moves into and out of the trachea and bronchi, butdoes not move into/out of the alveoli is called dead space ventilation.The body uses chemoreceptors to continuously measure the arterialblood's pH level and CO2 concentration. An elevated carbon dioxideconcentration (respiratory acidosis) stimulates the brain to increasealveolar minute ventilation by increasing the RR and/or TV. A decreasedcarbon dioxide concentration (respiratory alkalosis) stimulates thebrain to decrease minute ventilation by decreasing the RR and/or TV.Hypoventilation occurs when the alveolar minute ventilation does notexcrete the amount of carbon dioxide currently produced by cellularmetabolism. Hyperventilation occurs when the alveolar minute ventilationexceeds the amount of carbon dioxide currently produced by cellularmetabolism. Thus, known methods of measuring respiratory rate by airflowsuch as nasal cannula capnography and temperature thermistors are usedby clinicians to diagnose disordered breathing during a sleep apneastudy, as opposed to being awake and ambulatory. Capnographycontinuously samples air from one nostril using a nasal cannula, anddisplays a CO2 concentration waveform during inhalation/exhalation. Thetemperature thermistor measures changes in air temperature within onenostril during inhalation/exhalation (exhaled air warmer). Thesesemi-quantitative measures of respiration are used to detect apneas andhypopneas by correlating relative changes in airflow, but are not suitedto quantify the degree of upper airway function or level of ventilationimpairment.

SUMMARY

The techniques of this disclosure generally relate to a method, device,and system for an acoustic ventilation monitoring system.

In one aspect, a method of monitoring respiration with an acousticmeasurement device, the acoustic measurement device having a soundtransducer, the sound transducer configured to measure sound associatedwith airflow through a mammalian trachea includes correlating themeasured sound into a measurement of tidal volume and generating atleast one from the group consisting of an alert and an alarm if themeasured tidal volume falls outside of a predetermined range.

In another aspect, the measurement of sound associated with airflowthrough the trachea occurs at least periodically.

In another aspect, the acoustic measurement device includes a housing,and wherein the sound transducer is suspended within the housing.

In another aspect, the housing of the acoustic measurement device has awidth between 0.5 cm and 2.5 cm.

In another aspect, the housing defines an opening, and wherein the soundtransducer is disposed on an end of the housing opposite the opening.

In another aspect the housing is configured to releasably couple to skinof the mammalian trachea.

In another aspect the housing includes a diaphragm configured to vibratein response to sound.

In another aspect the housing is configured to engage coupling componentreleasably adhered to the skin, and wherein the coupling componentincludes the diaphragm.

In another aspect the housing includes a connector configured to engagethe coupling component.

In another aspect, the acoustic measurement device further includes anaccelerometer configured to measure a relative body position and amovement of the mammal, and wherein the method further includesmodifying the respective predetermined range on the mammal's relativeposition and movement.

In another aspect, the acoustic measurement device further includes atleast one from the group consisting of a device configured to measure apatient's cardiac electrogram, temperature, and blood oxygenation.

In another aspect, the method includes calculating at least one from thegroup consisting of a rate of change and trend direction of the measuredtidal volume, and wherein the at least one from the group consisting ofthe alert and the alarm is further generated if the calculated rate ofchange and trend direction of the tidal volume falls outside thepredetermined range.

In another aspect, the method includes filtering out ambient noise fromthe measured sound.

In one aspect, an acoustic measurement device includes a housingdefining a chamber therein, the housing defining a width and a length of2 cm or less, the housing defining an opening. A sound transducer isdisposed within the chamber opposite the opening; an adhesivesurrounding the opening. A wireless transmitter is in communication withthe sound transducer.

In another aspect, the housing is surrounded by a sound insulationmaterial except around the opening.

In another aspect, the device includes a diaphragm disposed within theopening and coextensive with a surface of the housing, the diaphragmbeing configured to resonate in response to sound.

In another aspect, the diaphragm is coupled to the sound transducer.

In another aspect, the device includes a power source coupled to thehousing, wherein the power source is configured to power the wirelesstransmitter.

In another aspect, the housing includes a first connector configured toengage a second connector of a coupling component, the couplingcomponent being configured to be adhered to the patient's skin, andwherein the coupling component includes an adhesive and a diaphragm, theadhesive being disposed about at least a portion of the second connectorand the diaphragm.

In one aspect, an acoustic ventilation monitoring system includes anacoustic measurement device, the acoustic measurement device includes ahousing defining a chamber therein, the housing defining a width and alength of 2 cm or less, the housing defining an opening and beingconfigured to releasably couple to a surface proximate a patient'strachea. A sound transducer is disposed within the chamber opposite theopening configured to measure sound energy emanating from the patient'strachea and lungs. A wireless transmitter is in communication with thesound transducer. A controller is in communication with the acousticmeasurement device, the controller being configured to: correlate themeasured sound energy into a measurement of the patient's tidal volumeand respiratory rate in real-time, assign a first value of a likelihoodof an adverse event based on the measured respiratory rate, assign asecond value of a likelihood of the adverse event based on the measuredtidal volume, calculate a rate of change of the measured respiratoryrate and tidal volume over time, assign a third value of a likelihood ofthe adverse event based on the calculated rate of change of the measuredrespiratory rate, assign a fourth value of a likelihood of the adverseevent based on the calculated rate of change of the measured tidalvolume, multiply the third value and the fourth value by a predeterminedweighing factor, and generate an alert if a sum of the first value, thesecond value, the third value, and the fourth value, exceeds apredetermined risk score threshold.

In one aspect, a method of predicting an opioid overdose with anacoustic measurement device, the acoustic measurement device having asound transducer, the sound transducer configured to measure soundassociated with airflow through a mammalian trachea includes correlatingthe measured sound into a measurement of tidal volume and generating atleast one from the group consisting of an alert and an alarm if themeasured tidal volume falls outside of a predetermined range, the atleast one of the alert and the alarm indicating a likelihood of anopioid overdose.

In another aspect, the measurement of sound associated with airflowthrough the trachea occurs at least periodically.

In another aspect, the acoustic measurement device includes a housing,and wherein the sound transducer is suspended within the housing.

In another aspect, the housing of the acoustic measurement device has awidth between 0.5 cm and 2.5 cm.

In another aspect, the housing defines an opening, and wherein the soundtransducer is disposed on an end of the housing opposite the opening.

In another aspect, the housing is configured to releasably couple toskin of the mammalian trachea.

In another aspect, the housing includes a diaphragm configured tovibrate in response to sound.

In another aspect, the housing is configured to engage couplingcomponent releasably adhered to the skin, and wherein the couplingcomponent includes the diaphragm.

In another aspect, the housing includes a connector configured to engagethe coupling component.

In another aspect, the acoustic measurement device further includes anaccelerometer configured to measure a relative body position and amovement of the mammal, and wherein the method further includesmodifying the respective predetermined range on the mammal's relativeposition and movement.

In another aspect, the method further includes calculating at least onefrom the group consisting of a rate of change and trend direction of themeasured tidal volume, and wherein the at least one from the groupconsisting of the alert and the alarm is further generated if thecalculated rate of change and trend direction of the tidal volume fallsoutside the predetermined range.

In another aspect, the method further includes filtering out ambientnoise from the measured sound.

In one aspect, a method of predicting an opioid overdose in a mammalincludes continually measuring sound waves emanating from an airflowinto and out of the mammalian trachea with an acoustic measurementdevice releasably affixable to the mammal's skin proximate the trachea.The measured sound is correlated into a measurement of the mammal'srespiratory rate and tidal volume. A direction trend and rate of changeof the respiratory rate and tidal volume at a predetermined interval arecalculated. During the predetermined interval, a value is assigned tothe mammal's (a) respiratory rate and tidal volume; (b) direction trendof the respiratory rate and tidal volume; and (c) rate of change of therespiratory rate and tidal volume. (a), (b), and (c) are summed. Atleast one from the group consisting of an alert and an alarm isgenerated if the sum of (a), (b), and (c) falls outside of apredetermined opioid risk range.

In another aspect, the method includes multiplying the assigned value ofat least one from the group consisting of (b) and (c) by a predeterminedweighting value.

In another aspect, the acoustic measurement device further includes anaccelerometer, and where the method further includes continuallymeasuring a mammal's activity level, body position, and snoring level;calculating a direction trend and rate of change of the measuredactivity level, body position, and snoring level at the predeterminedinterval. During the predetermined interval, a value is assigned to themammal's: (d) activity level, body position, and snoring level; (e)direction trend of the activity level, body position, and snoring level;and (f) rate of change of the activity level, body position, and snoringlevel. (a)-(f) is summed. The at least one from the group consisting ofthe alert and the alarm is generated if the sum of the (a)-(f) fallsoutside of the predetermined opioid risk range.

In another aspect, the method includes adhering an acoustic measuringdevice to the skin of the mammal proximate the trachea.

In another aspect, the acoustic measuring device is configured to be incommunication with a remote controller, the remote controller beingconfigured to carry out the recited method steps.

In another aspect, the method includes multiplying the assigned value ofat least one from the group consisting of (d), (e), and (f) by thepredetermined weighting value.

In another aspect, the acoustic measurement device is wireless.

In one aspect, a method of predicting an opioid overdose includes atleast periodically measuring sound energy emanating from an airflow intoand out of the mammal's trachea and lungs with an acoustic measurementdevice, the acoustic measurement device including a housing including atleast two sound transducers, the housing being sized and configured tobe adhered to a mammal's trachea with a coupling component, the housingdefining an opening, the at least two sound transducers being disposedwithin the housing opposite the opening. The measured sound is wirelesscommunicated to a remote controller, the remote controller beingconfigured to: correlate the measured sound energy into a measurement ofthe mammal's respiratory rate and tidal volume; assign a first value ofa likelihood of the opioid overdose based on the measured respiratoryrate; assign a second value of a likelihood of the opioid overdose basedon the measured tidal volume; calculate a rate of change of the measuredrespiratory rate and tidal volume at over the predetermined interval;assign a third value of a likelihood of the opioid overdose based on thecalculated rate of change of the measured respiratory rate; assign afourth value of a likelihood of the opioid overdose on the calculatedrate of change of tidal volume and generate at least one from the groupconsisting of an alert and alarm if the sum of the first value, thesecond risk, the third value, and the fourth value, exceed thepredetermined risk score threshold.

In one aspect, a method of predicting heat exhaustion or heat stroke inan ambulatory mammal includes at least periodically measuring soundemanating from an airflow through the mammal's trachea with an acousticmeasurement device, the acoustic measurement device including a housingincluding a sound transducer and a temperature sensor. The measuredsound is correlated into a measurement of the mammal's respiratory rateand tidal volume. A first value of a likelihood of at least one of heatexhaustion and heat stroke is assigned to the measured respiratory rateand a second value is assigned to the measured tidal volume. Themammal's temperature is measured at least periodically. A third value ofa likelihood of at least one of heat exhaustion and heat stroke isassigned to the measured temperature. At least one from the groupconsisting of an alert and an alarm is generated if a comparison betweenthe first value, second value, and third value exceeds a predeterminedrange.

In another aspect, the method includes multiplying at least one from thegroup consisting of the first value, the second value, and the thirdvalue by a predetermined weighting value.

In another aspect, the housing of the acoustic measurement device has awidth between 0.5 cm and 2.5 cm.

In another aspect, the housing defines an opening, and whereinpositioning the acoustic measurement device on the skin of the mammalincludes pressing the opening of the housing against the mammal's skin.

In another aspect, the sound transducer is disposed on an end of thehousing opposite the opening.

In another aspect, the housing includes a diaphragm configured tovibrate in response to sound disposed within the opening and pressedagainst the mammal's skin.

In another aspect, the diaphragm is directly coupled to the soundtransducer.

In another aspect, the acoustic measurement device further includes anaccelerometer configured to measure a relative body position and amovement of the mammal, and wherein the method further includes at leastperiodically modifying the predetermined range based on the mammal'srelative position and movement.

In another aspect, the acoustic measurement device further includes atleast one from the group consisting of a device configured to measure amammal's cardiac electrogram and blood oxygenation.

In another aspect, the method includes calculating at least one from thegroup consisting of a rate of change and trend direction of the sum ofthe first value and the second value, and wherein the at least one fromthe group consisting of the alert and the alarm is further generated ifthe calculated rate of change and trend direction of the sum of thefirst value and the second value deviates from the predetermined range.

In another aspect, the housing includes a first connector configured toengage a second connector of a coupling component, the couplingcomponent being configured to be adhered to the mammal's skin, andwherein the coupling component includes an adhesive and a diaphragm, theadhesive being disposed about at least a portion of the second connectorand the diaphragm.

In one aspect, a method of tracking fitness of an ambulatory mammalincludes at least periodically measuring sound emanating from airflowthrough an ambulatory mammal's trachea during exercise with an acousticmeasurement device releasably affixable to the mammal's skin proximatethe trachea, the acoustic measurement device including a housingincluding a sound transducer. The measured sound is correlated into ameasurement of the mammal's respiratory rate and tidal volume. Themammal's minute respiratory volume (MV) is calculated. The mammal's MVis compared with a predetermined MV threshold. The ambulatory mammal'sfitness is based on the comparison.

In one aspect, the housing of the acoustic measurement device has awidth between 0.5 cm and 2.5 cm.

In one aspect, the housing defines an opening, and wherein positioningthe acoustic measurement device on the skin of the mammal includespressing the opening of the housing against the mammal's skin.

In one aspect, the sound transducer is disposed on an end of the housingopposite the opening.

In one aspect, the housing includes a diaphragm configured to vibrate inresponse to sound disposed within the opening and pressed against themammal's skin.

In one aspect, the diaphragm is directly coupled to the soundtransducer.

In one aspect, the acoustic measurement device further includes anaccelerometer configured to measure a relative body position and amovement of the mammal, and wherein the method further includescontinuously modifying the respective predetermined threshold based onthe mammal's relative position and movement.

In one aspect, the acoustic measurement device further includes at leastone from the group consisting of a device configured to measure amammal's cardiac electrogram and blood oxygenation.

In one aspect, the housing includes a first connector configured toengage a second connector of a coupling component, the couplingcomponent being configured to be adhered to the mammal's skin, andwherein the coupling component includes an adhesive and a diaphragm, theadhesive being disposed about at least a portion of the second connectorand the diaphragm.

An Acoustic Ventilation Monitoring System (AVMS) is configured tomeasure and analyze a pattern of variables such as respiratory rate(RR), tidal volume (TV), upper airway patency (talking, snoring, apnea),body activity, body coordination, body position, heart rate, andtemperature in ambulatory and hospitalized patients. All of thesevariables may be analyzed in real-time to update a Risk-Index Score(RIS) that calculates the current and future risk of an adverse clinicalevent.

The AVMS determines whether an amount and pattern of minute ventilation(MV) and other variables are stable and within normal limits, orunstable and above or below the normal range. The diagnostic algorithmsmay produce alerts and alarms when they detect an unstable pattern of MVor the onset of mild, moderate, and severe hypoventilation orhyperventilation; based upon a change from an individual patient'sbaseline; or a change from a population baseline based upon height,weight, age, and sex.

In one configuration, the AVMS includes a wearable Trachea Sound Device(TSD) that transmits data to a diagnostic software application on thepatient's cell phone that alerts/alarms when it detects/predicts asignificant change in physiology that increases the immediate risk for aserious adverse event. The TSD continuously measures the sound of airmoving into and out of the trachea during inhalation. In oneconfiguration, the TSD includes two microphones, an accelerometer,circuitry, flash memory, a telemetry chip, software, and a rechargeablebattery housed within a miniature stethoscope head. In otherconfigurations, additional sensors and diagnostic algorithms thatquantify and analyze the ambulatory patient's electrocardiogram,hemoglobin oxygen saturation, and pulse oximeter waveform are included.In another configuration, the wearable TSD uses the electrocardiogramsignal and the pulse oximeter waveform signal to calculate theambulatory patient's blood pressure (BP) using pulse transmit time. TheTSD continuously communicates with a software application on thepatient's cell phone via low power Wi-Fi, Bluetooth, or other RFIDcommunications.

The AVMS continuously monitors the respiratory function of the patientusing real-time diagnostic algorithms based upon physiological modeling,pharmacologic modeling, machine learning, deep learning, and artificialintelligence methods. In one configuration, the user's smartphonetransmits key data to a central monitoring station for advanced analysisby a computer and clinician. Algorithms of the AVMS analyze theambulatory patient's amount and pattern of MV using the real-time RR andTV measurements produced by the TSD. The AVMS alerts/alarms to notifythe patient when the amount and pattern of MV is lower than normal(hypoventilation), higher than normal (hyperventilation), and/or anunstable pattern of MV. The AVMS continuously monitors MV and otherphysiological markers to determine stability of the patient'scardiovascular, pulmonary and metabolic systems during daily activities.The amount of alveolar minute ventilation directly correlates with theamount of cellular metabolism during normal lung function.

In one configuration, the AVMS continuously measures, analyzes, records,and displays the RR, TV, MV, airway patency, HR, body temperature, bodyactivity level, body coordination, and body position of an ambulatorypatient in the real-world environment; and a patient admitted to thehospital. Hospital clinicians may use the AVMS's real-time MV, HR, bodyactivity, and temperature trend data to manage inpatient medical therapyin a more efficient/effective/timely manner-leading to improved clinicaloutcomes and decreased costs.

The AVMS continuously monitors an ambulatory mammal's respiratory healthin their real-world environment during daily activities. In oneconfiguration, the system automatically alerts, for example, thepatient, family members, and caregivers by text, e-mail, and phone callwhen detecting or predicting an increased risk for a serious adverseclinical event. One embodiment automatically calls 911 emergencypersonnel with patient location and vital sign information. Anotherembodiment combines the AVMS with a wearable or implantable druginfusion pump with a closed-loop control algorithm. For example,outpatients and hospitalized patients taking opioid medication for acuteor chronic pain may wear the AVMS in communication with a patch pumpcapable of automatically infusing a bolus and/or infusion of the opioidreversal medication Naloxone (Narcan). The wearable TSD measures andprocesses the vital sign signals to enhance the signal-to-noise ratio.Data from the TSD is transmitted to the patient's cell phone (or othersmart device) for automated analysis by diagnostic algorithms. The smartdevice's algorithms continuously calculate a Risk-Index Score (RIS) fora variety of acute and chronic medical conditions to determine when toalert and alarm. Data may be transmitted from the patient's smart deviceto a central monitoring station's electronic medical record for advancedanalysis by a controller/computer and clinician. The controller mayautomatically summarize the data from the TSD and interpret theclinically significance in a brief written report to the patient,patient's physician's, patient's hospitals, and and/or a patient'scentral electronic medical record (EMR). Each patient has a detailedmedical/surgical history and medication list stored in the centralmonitoring station. The patient and caregivers may receive real-timealerts and alarms by text, e-mail, or phone call. Hospitals andphysicians can request summarized patient data from the centralmonitoring station's electronic medical record under HIPA guidelines. Inanother configuration, the AVMS functions as a fitness monitor thatcontinuously measures, records, and displays the ambulatory person'srespiratory rate, tidal volume (minute ventilation), heart rate,temperature, body position, and body activity level.

Clinicians interpret recorded and real-time AVMS data to diagnoseclinical deterioration and adjust outpatient medical therapy in a moreefficient/effective/timely manner—leading to improved clinical outcomesand decreased costs. Outpatients with congestive heart failure (CHF),ischemic heart disease, chronic obstructive pulmonary disease (COPD),asthma, pneumonia, cystic fibrosis, pneumoconiosis, musculardystrophies, pulmonary embolism, and other cardiovascular and pulmonarydiseases develop an unstable pattern of MV, HR, activity level, andtemperature during an episode of clinical deterioration. Patientscommonly experience an increase in the work-of-breathing (MV) thatpresents as shortness-of breath or dyspnea during daily activities. Aprolonged period of hard breathing causes fatigue. For example,outpatients with worsening congestive heart failure (CHF) have anincrease in the work-of-breathing (MV) due to an increase in pulmonaryedema (lung water), a decrease in lung compliance, and a low bloodoxygen concentration. The heart rate and body temperature also increasedue to an increase in cellular metabolism, cardiac work, and hypoxemia.An increase in the work-of-breathing is commonly described by thepatient as an increase in shortness-of-breath during daily activities. Aprolonged period of increased work-of-breathing causes the patient toexperience the signs and symptoms of fatigue.

An outpatient with respiratory insufficiency/failure due to worseningbronchitis, emphysema, asthma, pneumonia, etc. develops an increase inthe work-of-breathing (MV) in response to a decrease in the blood oxygenconcentration (hypoxemia), an increase in the blood carbon dioxideconcentration (hypercarbia), and/or a decrease in lung volumes.Worsening lung function is caused by airway narrowing, airwayobstruction, increased lung water, infection, secretions, and skeletalmuscle weakness and fatigue. Decompensation may cause an increase in theRR, TV, MV, HR, body temperature, prolonged exhalation time, andincrease the amount of coughing, wheezing, sneezing, yawning,swallowing, and clearance of airway secretions.

The AVMS continuously monitors the MV of a patient taking opioids and/orother medications that cause respiratory depression (for example:morphine, codeine, fentanyl, carfentanil, midazolam, propofol, opium,heroin, methadone, valium, alcohol, and sleeping pills, (Ambien®,Dalmane®, Halcion®, Lunesta®, Prosom®, Restoril®, Rozerem®, Silenor®,Sonata®, Desyrel®, and Belsomra®). This AVMS has diagnostic algorithmsoptimized to detect/predict the onset and progression of mild tomoderate to severe hypoventilation due to opioids and other medicationsthat cause respiratory depression prior to a severe hypoventilationevent, as discussed in more detail below.

The AVMS may continuously measure and analyze the MV of hospitalizedpatients during monitored anesthesia care (MAC) anesthesia withspontaneous ventilation (for example during: regional anesthesia, GIendoscopy, cardiac catheterization, and radiology procedures).Anesthesiologists may use the AVMS to continuously monitor the patient'sMV and airway patency in the operative room (OR), Post-Anesthesia CareUnit (PACU), and the Intensive Care Unit (ICU). Hospital clinicians mayuse the system to continuously monitor the patient's MV and airwaypatency during sedation procedures in the emergency room, radiologysuite, and cardiac catheterization laboratory. Floor nurses may use theAVMS to continuously monitor the patient's MV when managed with opioidsand other medications that cause respiratory depression. In oneembodiment, medical and surgical patients in the hospital may becontinuously monitored using the AVMS with real-time alerts and alarms.The MV trend data is displayed at the bedside and nursing station, andautomatically uploaded into the hospital's EMR.

Patients taking opioids and/or other medications that cause respiratorydepression at hospital discharge may continue to be monitored at homeusing the AVMS, with data transmitted to a software application on thepatient's cell phone. For example, elderly patients undergoing a hip orknee replacement orthopedic surgery are routinely discharged from thehospital 24 to 48 hours post-operatively—with a prescription for 5 to 7days of an oral opioid medication for acute pain control. Hospitals,physicians, and nurses may use the AVMS after hospital discharge toenhance patient safety, improve clinical outcome, and minimize the riskof a malpractice lawsuit. Clinicians can download the recorded data toevaluate patient safety and adherence/compliance to the treatment plan.The AVMS can be used in a similar way to enhance the safety andcompliance of patients with an opioid-use disorder being treated in aninpatient/outpatient drug rehabilitation (methadone) clinic.

Humans develop a typical pattern of respiratory depression following alarge dose of an opioid (alone or mixed with alcohol or sedatives)characterized as a progressive decrease in RR, a decrease in TV, adecrease in talking, an increase in snoring, a decrease in bodyactivity, a progression from coordinated to uncoordinated movements, achange from the upright to the lateral/supine/prone position, anunstable heart rate, and/or an unstable body temperature. Themicrophones and accelerometer qualify the amount and pattern of headbobbing, snoring, body activity level, body coordination, and bodyposition in real-time to determine the degree of sedation. Sensor datamay be transmitted via the patient's smart device (smart phone, smartwatch, tablet PC, Alexa, cable box) to a central monitoring station'selectronic medical record for advanced analysis by a computer andclinician. A brief summary of an important event may be transmittedelectronically to the patient, the patient's physicians, and thepatient's hospitals for download into their electronic medical record(EMR).

Patients with an opioid abuse disorder may be treated in anoutpatient/inpatient drug and alcohol rehabilitation clinic with theAVMS to prevent brain damage and death due an opioid overdose.Progressive alerts and alarms may be sent to the patient's cell phone,caregivers' cell phones, and/or emergency personnel (911 with location).Clinicians may prescribe the real-time AVMS for safety fromhypoventilation and compliance prior to prescribing the next dose ofmethadone. Sensor data may be downloaded during each clinic visit toevaluate the patient's RIS for hypoventilation since the last visit. Inone configuration, patients are required to continuously use the AVMS inorder to obtain their next dose of methadone. Recent guidelines from theHospital Joint Commission and the Center for Medicare and Medicaid callsfor all hospitalized patients being managed with opioid medication to becontinuously monitored with alarms. Hospital nurses currently monitorpatients managed with opioids by assessing the adequacy of ventilationintermittently by observing the depth of breathing and by measuring thenumber of breaths/minute. Hospitalized patients may be continuouslymonitored using a hard-wired pulse oximeter, capnometer, or electricalimpedance monitor.

In another configuration, the AVMS automatically triggers anauto-injector device (not shown) to deliver an opioid reversalmedication (for example naloxone) into the subcutaneous tissue (savinglives). This AVMS may continuously monitor the ventilation status of anambulatory patient taking opioids in real-time and automaticallydelivers an opioid antidote when the device detects/predicts high riskfor an opioid overdose. The auto-injector may deliver one or moreboluses of naloxone or continuously infuse naloxone into thesubcutaneous tissue based upon the real-time AVMS data using aclosed-loop control algorithm. In another configuration, amateurathletes, professional athletes and the military may use the AVMS tomonitor their fitness during exercise and to optimize physical fitness.Performance training is evaluated and optimized using objectivemeasurements of MV, heart rate (HR), and body temperature in relation tothe level and duration of exercise. Athletes and soldiers adapt theirtraining program to enhance stamina and endurance using the objectivemeasurements of RR, TV, MV, HR, and temperature. The military andprofessional versions of the wearable AVMS fitness monitordetect/predict the onset of overheating/exhaustion with alerts andalarms prior to an adverse clinical event.

In another configuration, the AVMS also monitors the ambulatory person'selectrocardiogram, percent hemoglobin oxygen saturation, and the pulseoximeter waveform. The electrocardiogram monitors the ambulatorypatient's heart rate, heart rhythm and ST segment depression/elevationin relation to the work-of-breathing, HR, and level of activity. Thereflectance pulse oximeter monitors the heart rate, hemoglobin oxygensaturation, pulse waveform, and an estimate of thesystolic/mean/diastolic blood pressure (using pulse transit timemeasurement and analysis of the photoplethysmograph waveform). Thesystem can automatically turn the pulse oximeter and electrocardiogramon/off at a set schedule to save battery power; or turn them on onlywhen the algorithms detects or predicts a significant change in the RIS.

In one configuration, the TSD is adhered to the skin surface adjacent tothe larynx and/or proximal trachea. Microphones measure the sound of airmoving with the trachea lumen during inhalation and exhalation. The AVMSanalyzes the sound information to accurately estimate respiratory rate(RR), tidal volume (TV), number and duration of apnea episodes, anddegree of upper airway obstruction (snoring). Real-time TSD data may berecorded, downloaded, analyzed, and displayed on any smart device withwireless communication. Data may be transferred to a central monitoringstation for advanced analysis by a computer and clinician. The devicemay alert and alarm when the algorithms detects a significant change inphysiology, based upon a real-time RIS. The risk-index algorithm'sability to detect/predict at which point during treatment with an opioiddoes mild, moderate, and severe hypoventilation actually occur. Thedegree of hypoventilation during hospital care and research studies maybe based upon the concentration of carbon dioxide in artery blood(PaCO2). For example, the algorithm is contoured to detect mildhypoventilation (PaCO2-45 to 50 mm Hg) due to an opioid overdose withhigh sensitivity (>90%) and specificity (>90%), moderate hypoventilation(PaCO2-51 to 60 mm Hg) due to an opioid overdose with high sensitivity(>95%) and specificity (>95%), and severe hypoventilation (PaCO2>60 mmHg) due to an opioid overdose with high sensitivity (>99%) andspecificity (>99%). The algorithms use a RIS to accurately detect andpredict the onset of mild, moderate, and severe hypoventilation prior asevere hypoventilation event due to a medication overdose (opioids,alcohol, benzodiazepam, etc.) or other medical conditions.

In this configuration, the AVMS includes a wearable TSD thatcontinuously measures the volume of air flowing through the patient'smid-trachea during each inhalation and exhalation (ml/kg/minute). TheTSD uses microphone sound data and 3-axis accelerometer data toaccurately measure respiratory rate (RR), tidal volume (TV), minuteventilation (MV), the timing of inhalation/exhalation, degree of upperairway obstruction (talking, snoring, apnea), body activity level, bodycoordination, and body position. A typical tidal volume (TV) at rest isapproximately 500 ml/breath (amount of air moved into the body duringinspiration and out of the body during exhalation). Thus, a typicaladult person at rest may have a minute ventilation of approximately 6000ml/minute (12 breaths/min×500 ml tidal volume/breath=6 L/min). Thenormal minute ventilation during a period of rest ranges from 5 to 8L/minute in adult humans. Minute ventilation during light activities mayincrease to 12 L/minute, and may increase to >40 L/minute duringmoderate exercise.

The real-time algorithms may analyze the amount and pattern of theambulatory patient's breathing (RR×TV=MV) to determine the “Work ofBreathing” in relation to the level of body activity. The algorithms mayaccurately quantify the degree of hypoventilation, hyperventilation,hypopnea, hyperpnea, tachypnea, bradypnea, apnea and other abnormalpatterns of ventilation.

Hypoventilation is defined as an elevated partial pressure of carbondioxide in the blood (PaCO2>45 mm Hg) due to insufficient minuteventilation relative to the metabolic production of CO2.Hyperventilation is defined as a decreased partial pressure of carbondioxide in the blood (PaCO2<35 mm Hg) due to excessive minuteventilation relative to the metabolic production of CO2. Hypopnea isdefined as overly shallow breathing or an abnormally low respiratoryrate. Hyperpnea is defined as an increased depth and rate of breathing.Bradypnea is defined as abnormally slow respiratory rate. Tachypnea isdefined as abnormally fast respiratory rate. Apnea is defined as a pausein breathing, where there is no movement of the muscles of inhalation orchest wall (for example >15 seconds), and the volume of the lungsremains unchanged.

The TSD may also monitor upper airway patency/degree of airwayobstruction (normal sound patterns, talking, snoring), body activity,body position, and body coordination to determine the sleep/awake cycleand estimate of the level of sedation. The TSD may also monitor theamount and pattern of coughing, sneezing, wheezing, yawning, swallowing,and clearance of airway secretions.

In one configuration, the wearable TSD includes telemetry to a cellphone application and is approximately a dime-sized sensor (for example1.0 cm diameter×0.675 cm height) that reliably transmits trachea soundand accelerometer data to an adjacent cell phone. The miniature sensoris easily attached to/detached from the disposable ring and adhesivebase (for example 2.0 cm diameter×0.2 cm height) with a twist and clickmotion. This disposable base can be adhered to the skin over the tracheaimmediately above the sternal notch or lateral to the larynx for up to14 days, while the sensor can be easily attached/detached from the baseas needed for recharging the battery. In addition, the tracheal soundscan be signal processed and analyzed using frequency versus time curvesand amplitude versus time curves to diagnose a normal pattern ofinhalation and a normal pattern of exhalation (clear uninterrupted soundpattern) in contrast to abnormal inhalation/exhalation sounds. Sleepapnea and other pathological conditions commonly cause intermittentupper airway obstruction that can lead to hypoventilation, hypoxemia,arrhythmias, pulmonary hypertension, and heart failure. Opioids,alcohol, illegal drugs, and other medications that cause sedation maycause relaxation of the upper airway muscles, leading to mild tomoderate to severe upper airway obstruction (snoring and obstructiveapnea). Analysis of the partially obstructed upper airway sound patternscan be used to diagnosis the progression of airway muscle relaxation asan estimate of the severity of sleep apnea or the degree of centralnervous system sedation.

The wearable TSD incorporates microphones and an accelerometer on amotherboard containing electronics, flash memory, a telemetry chip, anda rechargeable battery. The wearable TSD may incorporate an additionalmicrophone (on the TSD or the cell phone) as an input for ambient noisecancellation and noise suppression. The wearable TSD is mechanicallyadhered to the skin over the proximal trachea (in the midline just abovethe sternal notch or adjacent to the larynx) by a small plastic basewith an adhesive pad and maybe include coloring to match the skin toneof the patient to increase acceptance of the wearable TSD. The base maymechanically couple a flexible diaphragm to the skin over the proximaltrachea. The wearable TSD can be easily attached/detached from theadhesive base with a twist and click motion. The sensor base can stayadhered to the skin for up to 2 weeks, while the wearable TSD can bechanged out every few days for recharging the battery. The TSD'smicrophones may be positioned at the focal point above the diaphragm toaccurately measure the sound of air movement within the trachea duringinhalation/exhalation.

The monitoring system may have progressive alerts and alarms to thepatient's cell phone, a caregiver, and/or 911 emergency personnel (withlocation). The wearable TSD can also transmit data to a bedside hospitalmonitor or a nurse's smart device for analysis and display. The AVMSfurther has the capability of predicting the onset of opioid inducedrespiratory depression (hypoventilation) using a real-time RIS updated,for example, every 20 to 30 seconds.

Physicians and nurses that manage outpatients with chronic pain can usethe AVMS as an objective way to enhance clinical safety, patienteducation, and compliance with taking their prescribed pain medication.Sensor data may be downloaded during each clinic visit to evaluate thepatient's RIS for hypoventilation. Physicians and physician assistantsmay prescribe short-term use of the wearable TSD following initiation ofopioid therapy, and an escalation in opioid dose. Humans developing anopioid overdose typically develop a progressive decrease in RR, adecrease in TV, progression from normal ambulation to uncoordinatedmovements, decreased talking, increased snoring, decreased bodyactivity, and a change from the upright to lateral/supine/pronepositions.

In addition, a wide variety of pathological conditions can causehypoventilation, for example, severe obesity (obesity-hypoventilationsyndrome), neuromuscular disorders (e.g., amyotrophic lateral sclerosis,muscular dystrophies with diaphragm paralysis, Guillain-Barré syndrome,myasthenia gravis, etc.), chest wall deformities, obstructive sleepapnea, chronic obstructive lung disease, ischemic brain injury,neurologic disorders (e.g., encephalitis with brainstem disease, trauma,poliomyelitis, multiple sclerosis, etc.),central alveolarhypoventilation, and sudden infant death syndrome among other disordersand diseases.

Some embodiments advantageously provide a method and system formonitoring a patient's breathing, the method including positioning anacoustic measurement device on the skin of a patient proximate one ofthe trachea and/or a lateral neck region of the patient. The acousticmeasurement device may include a housing defining a chamber and a soundtransducer suspended within the chamber. The method further includesmeasuring at least one from a group consisting of a respiratory rate anda tidal volume with the acoustic measurement device. The measurement ofthe at least one from the group consisting of the respiratory rate andthe tidal volume is transmitted to a remote controller. The remotecontroller is configured to compare the measurement of the at least onefrom the group consisting of respiratory rate and tidal volume to arespective one of a fixed or a dynamic threshold and determine anadverse event in real time if the measurement of the at least one fromthe group consisting of respiratory rate and tidal volume deviates fromthe respective predetermined threshold by a predetermined amount.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of embodiments described herein, and theattendant advantages and features thereof, may be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a cross-sectional view of embodiment of an acoustic sensorconstructed in accordance of the principles of the present applicationand a view of the acoustic sensor coupled to a patient's body;

FIG. 2 is a cross-sectional view of another embodiment of an acousticsensor constructed in accordance of the principles of the presentapplication;

FIG. 3 is a cross-sectional view of another embodiment of an acousticsensor constructed in accordance of the principles of the presentapplication;

FIG. 4 is a cross-sectional view of another embodiment of an acousticsensor constructed in accordance of the principles of the presentapplication;

FIG. 5 is a cross-sectional view of another embodiment of an acousticsensor constructed in accordance of the principles of the presentapplication;

FIG. 6 is another a cross-sectional view of embodiment of an acousticsensor constructed in accordance of the principles of the presentapplication;

FIG. 7 is a flow chart showing exemplary steps of determining apatient's risk index score for an opioid overdose in accordance with anembodiment of the present application;

FIG. 8 is a flow chart showing exemplary steps of determining apatient's risk index score to determine a patient's risk for heat strokeor heat exhaustion;

FIG. 9 is a flow chart showing exemplary steps of determining apatient's fitness level based in part on minute ventilation (MV) inaccordance with an embodiment of the present application;

FIG. 10 is a flow chart showing exemplary steps of determining apatient's risk index score to determine a patient's risk ofdecompensation due to asthma and chronic obstructive pulmonary disease(COPD) in accordance with an embodiment of the present application; and

FIG. 11 is another cross-sectional view of embodiment of an acousticsensor constructed in accordance of the principles of the presentapplication and a top cross-sectional view of a coupling component ofthe present application.

DETAILED DESCRIPTION

Before describing in detail exemplary embodiments, it is noted that theembodiments reside primarily in combinations of apparatus components andprocessing steps related to an acoustic sensor system and related methodthereof. Accordingly, the system and method components have beenrepresented where appropriate by conventional symbols in the drawings,showing only those specific details that are pertinent to understandingthe embodiments of the present disclosure so as not to obscure thedisclosure with details that may be readily apparent to those ofordinary skill in the art having the benefit of the description herein.

As used herein, relational terms, such as “first” and “second,” “top”and “bottom,” and the like, may be used solely to distinguish one entityor element from another entity or element without necessarily requiringor implying any physical or logical relationship or order between suchentities or elements. The terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting of the concepts described herein. As used herein, the singularforms “a”, “an” and “the” are intended to include the plural forms aswell, unless the context clearly indicates otherwise. It may be furtherunderstood that the terms “comprises,” “comprising,” “includes” and/or“including” when used herein, specify the presence of stated features,integers, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this disclosure belongs. It may befurther understood that terms used herein should be interpreted ashaving a meaning that is consistent with their meaning in the context ofthis specification and the relevant art and may not be interpreted in anidealized or overly formal sense unless expressly so defined herein.

In embodiments described herein, the joining term, “in communicationwith” and the like, may be used to indicate electrical or datacommunication, which may be accomplished by physical contact, induction,electromagnetic radiation, radio signaling, infrared signaling oroptical signaling, for example. One having ordinary skill in the art mayappreciate that multiple components may interoperate and modificationsand variations are possible of achieving the electrical and datacommunication.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processors, such as one ormore digital signal processors (DSPs), general purpose microprocessors,application specific integrated circuits (ASICs), field programmablelogic arrays (FPLAs), or other equivalent integrated or discrete logiccircuitry. Accordingly, the term “processor” as used herein may refer toany of the foregoing structure or any other physical structure suitablefor implementation of the described techniques. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

With reference to FIGS. 1-6, an acoustic measurement device or TSD 10 isdepicted which is sized and configured to be releasably affixed to theskin of a mammal. The device 10 includes a housing 12 defining an atleast partially enclosed chamber 14 therein. In one configuration, thehousing 12 defines a width and a length of 2 cm or less. For example,the housing 12 may be substantially cube shaped having a width of 2 cmor less, such as between 0.5 cm to 2.5 cm, a sphere or disc having adiameter of 2 cm or less, or another shape suitable for affixing to thepatient.

The housing 12 may be composed of one or more materials, such as alightweight plastic, metal, ceramic, or composite having integrated oradded sound insulation material 16 on an exterior thereof, lining theinterior of the chamber 14, or both, to attenuate ambient sound. Thewalls of the housing and lining may be separated by an air-filled spacedesigned to attenuate ambient sound. The housing 12 may be manufacturedfrom materials and structure that attenuates transmission of ambientsound into the chamber 14. In one configuration, an airtight seal isformed between the housing 12 and skin surface to isolate the inside ofthe TSD 10 from the external environment. In an alternativeconfiguration, the housing 12 may be porous or have an external openingsuch that sound may penetrate the housing 12 from an ambientenvironment, depending on the application. In one configuration, thehousing 12 defines a single opening 18 to provide access to the chamber14; however, the number and size of the openings 18 are not limited to aparticular number and size. The sound insulation material 16 maysurround the housing 12 in all areas with the exception of around theopening 18. The housing 12 may define a dome shape, bell shape, (FIG. 6)or any shape such that the chamber 14 is isolated from external soundsand optimized to measure the sounds of air movement within the trachea.

One or more sound transducers 20 may be affixed, either permanently orremovably, within the chamber 14 of the housing 12 for measuring atleast one of a respiratory rate and a tidal volume of the patient. Thesound transducer 20 may be one or more microphones, for example, in the20-2000 Hz range, configured to measure sound energy within the chamber14 and transduce an acoustic signal into a digital signal. The miniatureelectronic microphones (electric, piezoelectric, or MEMS) transduce themechanical vibrations caused by airflow within the proximal tracheaduring inhalation and exhalation with a high signal-to-noise ratio. Inone configuration, the sound transducer 20 is located at an end of thehousing 12 opposite an end of the housing 12 defining the opening 18 andmay be suspended within the chamber 14 using, for example, an elongaterod or other suspension element (not shown) extending from the interiorsurface of the chamber 14 such that the sound transducer 20 is not incontact with the interior walls of the housing 12.

A flexible diaphragm 22 may be disposed within the opening 18 that iscoextensive or slightly recessed within a surface of the housing 12. Thediaphragm 22 may be a thin flexible material that resonates in responseto sound energy, for example airflow through the trachea of a mammal, ina manner similar to a pediatric stethoscope head. In one configuration,the diaphragm 22 is electrically coupled to the sound transducer 20 suchthat when the diaphragm 22 resonates, the sound vibration is directlymeasured by the sound transducer 20. In other configurations, ratherthan being coupled to the diaphragm 22, the sound transducer 20 is inclose proximity to the diaphragm 22, for example, immediately adjacentthereto to minimize any ambient sound measured by the sound transducer20. In other configurations, the diaphragm 22 is the actual diaphragm ofthe sound transducer 20 and is directly coupled to an electromagneticcoil, capacitor, or piezoelectric crystal of the sound transducer 20. Inone configuration, the interior of the housing 12 may define a curvedsemi-circle, dome, or other shape to focus the sound energy transducedfrom the skin surface directly into the diaphragm 22. For example, thesound transducer 20 and diaphragm 22 may be angled and positioned in amanner to measure sounds of the airflow as it enters and exits thelarynx. In other configurations, the sound transducer 20 and thediaphragm 22 are aimed toward the airflow through the trachea.

Continuing to refer to FIGS. 1-6, a wireless transmitter 24 may becoupled to the housing 12, which is in communication with the soundtransducer 20. The wireless transmitter 24, which may transmit andreceive, is configured to transmit the transduced acoustic signalmeasured by the sound transducer 20. In one configuration, the wirelesstransmitter 24 is included as part of a processing circuitry having oneor more processors included within the housing 12. For example, thewireless transmitter 24 may transmit the measurement of the respiratoryrate, the tidal volume, the heart rate, or other vital sign data, to aremote controller 26 which forms the AVMS 27 in combination with the TSD10. The remote controller 26 may be in the form of a smartphone, tablet,smartwatch, Echo™ device, Alexa™ device, cable box, or other mobilecommunication device configured to be held, coupled to, or in proximityto the patient, that communicates with the device 10 by Bluetooth® orWiFi®, or another electronic handshake such that acoustic informationmay be relayed to the controller 26 for real-time processing. Thecontroller 26 may further include processing circuitry with one or moreprocessors to process the data received from the TSD 10. The results ofsuch processing may be displayed on the display of the controller 26 ortransmitted by the controller 26 to a remote location for furtherprocessing and/or analysis.

The wireless transmitter 24 and the sound transducer 20 may be poweredby a same rechargeable power source 28, for example, a rechargeablebattery. The power source 28 may be charged by induction or wirelessly,thereby remaining coupled to the device 10 during charging. In otherconfigurations, the sound transducer 20 and wireless transmitter 24 mayhave separate power sources. Although the power source 28 is shown asbeing smaller size wise relative to some other components of device 10disclosed herein, it is noted that the illustrated size of the powersource 28 is merely exemplary and may be any shape or size.

Referring back to FIG. 1, the TSD 10 may include an adhesive 30 adheredto the patient's skin proximate one of the tracheal notch or a lateralneck region of the patient to measure sound and/or vibrations associatedwith the patient's breathing. The adhesive 30 may also at leastpartially surround the opening 18. The adhesive 30 may be a double-sidedtape or pad or other removable adhesive which allows the device 10 to bereleasably adhered to the skin of the patient after remaining affixed tothe patient for a predetermined period of time, for example, 3-14 days.In one configuration, the adhesive 30 surrounds the opening 18 on thesurface of the housing 12 without occluding or otherwise blocking theopening 18 to avoid interfering with sound waves entering the chamber14.

In an exemplary configuration, the controller 26 is configured tocompare the measurement of at least one of the respiratory rate and thetidal volume to a respective predetermined threshold, which may be arange or value, or patient baseline with the RIS discussed above. Forexample, the average respiratory rate for a sedentary person isapproximately 12-15 breaths per minute. A typicalinhalation(inspiration) period is approximately 1 second, followed by a2 second pause, followed by a 2 second period of exhalation(expiration).The period of exhalation is always longer than the period of inhalation.Faster respiratory rates decrease the amount of time during each periodof the respiratory cycle. The pause between breaths may become shorterwith a rapid respiratory rate.

In contrast to the rapid respiratory rate, the amount of time duringeach inhalation and exhalation period increases with a slow respiratoryrate, and the pause may become longer. A typical tidal volume, theamount of air moved into the body during inhalation and out of the bodyduring exhalation, at rest, is approximately 500 ml/breath. Thus, atrest, a typical person has a minute ventilation of approximately 6000ml/minute (12 breaths/min×500 ml tidal volume/breath=6 L/min).Physiologists have determined the normal range of respiratory rate,tidal volume, and minute ventilation at rest and during activity forneonates, children, adolescents, adults, and geriatric adults based onheight, weight, age, and gender. Based on these predetermined knownparameters, the controller 26 is configured to determine an adverseevent, such as hypoventilation caused by a drug overdose, in real time,if the measurement of at least one of the respiratory rate and the tidalvolume falls outside of a respective predetermined range by apredetermined amount.

For example, controller 26 may establish an adverse event risk indexscore (RIS), which may be a predetermined range, based on the percentagechange, absolute change, or rate of change from predetermined knownparameters or baseline. For example, the percentage change may bebetween 5%-50%, or more, from the predetermined known parameters. Such apercentage is merely exemplary and may be set by a clinician based onthe patient's own tidal volume and/or respiratory rate measurements whenactive and when at rest and the controller 26 may be configured tochange the patient's baseline based on observed breathing patterns. Forexample, the controller 26 may employ algorithms (machine-learning, deeplearning, artificial intelligence, and/or neural networks) to recognizea distinct pattern from the patient's usual baseline pattern. In oneexample, hypoventilation may cause higher levels of arterial carbondioxide, which in turn produces greater sedation, less movement,snoring, head bobbing, uncoordinated movements, which can be detected byan activity sensor/accelerometer, described in more detail below. Forexample, a risk index score of “30” could produce an alert, a risk indexscore of “40” could produce a warning, and a risk index score>“50” couldproduce an alarm and/or an automated injection of an opioid reversalmedication (for example, Naloxone or Narcan). Also, for example, thedevice 10 could produce a low alert with a 20-30% change of RR and/or TVsuggesting impending hypoventilation, a medium alert with a 30-50%change, and a red alert/alarm with >50% change from baseline. The AVMS27 may have threshold alerts/alarms and predictive alerts/alarms thatwarn the patient and/or clinician of an increased risk for an adverseevent and/or a serious adverse event with a negative clinical outcome.

As mentioned above, adverse events may include hypoventilation, which isdefined as an elevated partial pressure of carbon dioxide in the blood(PaCO2>45 mm Hg) due to insufficient minute ventilation relative to themetabolic production of CO2. In addition, such adverse events mayinclude hyperventilation which is defined as a decreased partialpressure of carbon dioxide in the blood (PaCO2<35 mm Hg) due toexcessive minute ventilation relative to the metabolic production ofCO2, hypopnea which is defined as overly shallow breathing or anabnormally low respiratory rate, bradypnea which is defined asabnormally slow respiratory rate, hyperpnea which is defined as anincreased depth and rate of breathing, tachypnea which is defined as anabnormally rapid respiratory rate, and apnea which is defined as a pausein breathing where there is no movement of the muscles of inhalation andthe volume of the lungs remain unchanged.

The controller 26 may apply low pass and high pass filters to themeasured data to filter out anomalous data and ambient noise. Anexternal microphone may be used for ambient noise suppression and noisecancelling. In one configuration, tracheal sounds may be analyzed by thecontroller 26 using frequency versus time curves and amplitude versustime curves to diagnose a normal pattern of inhalation and a normalpattern of exhalation (i.e., clear uninterrupted sound patterns)relative to abnormal inhalation/exhalation sounds or sound patterns.Sleep apnea and other pathological conditions of the brain and upperairway commonly cause intermittent upper airway obstruction that canlead to hypoventilation, hypoxemia, arrhythmias, pulmonary hypertension,and heart failure. Opioids, alcohol, illegal drugs, or medications thatcause sedation, relax the upper airway muscles, leading to mild,moderate, or severe upper airway obstruction (snoring and obstructiveapnea). As such, analysis of the partially obstructed upper airway soundpatterns can be used to diagnose the progression of airway musclerelaxation as an estimate of the severity of sleep apnea or the degreeof central nervous system sedation.

Continuing to refer to FIGS. 1-6, the device 10 may further include anaccelerometer 32, a temperature sensor 34, and/or a reflectance pulseoximeter 36, which may be positioned within the housing 12 and coupledto the power source 28 in communication with the controller 26. The3-axis accelerometer 32 may be configured to measure a relative x-y-zposition and a movement of the patient, such as the amount and patternof head bobbing, body movement, body coordination, and body position inreal-time to further estimate, in the case of a drug overdose, thedegree of sedation and the trends of sedation over time. Theaccelerometer 32 also senses chest wall movement to monitor theonset/timing of inhalation and exhalation. The temperature sensor 34 maybe integrated within the housing and used to detect a decrease orincrease in body temperature. The reflectance pulse oximeter 36 may beconfigured to monitor percent hemoglobin oxygen saturation and thephotoplethysmograph waveform, whether continuously, intermittently, orwhen the algorithm detects/predicts the onset of hypoventilation or achange in health. The pulse oximeter's waveform can be analyzed inreal-time to estimate heart rate, heart rate variability, stroke volume,stroke volume variability, pre-load, myocardial contractility, systemicvascular resistance, cardiac output, and systemic blood pressure.

In one configuration, the device 10 may also measure the patient'scardiac electrogram or electrocardiogram to determine the real-timeheart rate and heart rhythm. For example, the device 10 may include aplurality of electrodes 38 (FIG. 11) positioned on, for example, aportion of the housing 12 in contact with the patient's skin to measurethe patient's electrocardiogram. The method of pulse-transit time canutilize the electrocardiogram signal and the pulse oximeter 36plethysmograph signal to calculate the systemic blood pressure. Theelectrocardiogram and pulse oximeter signals measured by the TSD 10 wornon the body may communicate wirelessly with the ambulatory patient'ssmart watch that also contains skin electrodes that measure theelectrocardiogram and pulse oximeter signals at the wrist, to enhancethe signal-to-noise ratio and clinical performance.

In one configuration, the device 10 may also measure the patient'scardiac electrogram or electrocardiogram to determine the real-timeheart rate and heart rhythm. For example, the device 10 may include aplurality of electrodes 38 (FIG. 11) positioned on, for example, aportion of the housing 12 in contact with the patient's skin to measurethe patient's electrocardiogram. The method of pulse-transit time canutilize the electrocardiogram signal and the pulse oximeter 36plethysmograph signal to calculate the systemic blood pressure. Theelectrocardiogram and pulse oximeter signal may communicate wirelesslywith an electrocardiogram and pulse oximeter signal on the ambulatorypatient's smart wrist watch to enhance the signal-to-noise ratio andclinical performance.

Referring now to FIG. 5, in another configuration, the sound transducer20 may include a vibration sensor (electric, piezoelectric, or MEMS)configured to measure vibrations as a result of air flowing into and outof the trachea or lungs. The sound transducer 20 may be substantiallyplanar with the skin of the patient to increase mechanical coupling andsensitivity. The vibration sensor accelerometer 32 and the power source28 may be integrated into the housing 12. For example, a MEMS device maybe integrated within a first chamber 38 of the housing 12 separated fromthe sound transducer 20. The MEMS device may further be configured toprocess information from one or more of the sensors disclosed hereinwhich may be included in this configuration. The MEMS device may beincluded in any of the embodiments discussed above.

Referring now to FIG. 7, as discussed above, the controller 26 mayemploy a method to assign a risk index score to a wearer of the device10, such risks may include as discussed above an opioid overdose. Themethod includes continuously, intermittently, or continually measuringthe RR and TV of the patient wearing the device 10. In oneconfiguration, the controller 26 further measures at least one from thegroup consisting of the user's activity level (AL), body position (P),snoring sounds (S), and body coordination (BC). The controller 26 maythen further calculate the user's absolute RIS using the values for RR,TV TD, AL, P, S, and/or BC, the direction trend of each value over time,and the rate of change of each value and the sum of all the values toestablish a predictive score for an opioid overdose. The absolute RISmay be calculated and updated every 20 to 30 seconds, or any periodic orcontinual interval. Alerts and alarms may be based upon the absolute RISnumber, the RIS direction of change, and the RIS rate of change overtime.

For example, the AVMS may continuously measure the RR and TV and thecontroller 26 may calculate the averaged RR and TV over a predeterminedperiod of time (x), for example each 20 to 30 second interval. Thecontroller 26 may then assign a risk value represented as a value (F),to score that particular parameter based on a predefined scale anddetermine if an alert (warning) or an alarm (urgent) is to be generated.For example, as shown in TABLE 1, a respiratory rate (RR) of 15 to 14breaths/minute is assigned an F value of zero to −4 (low risk), a RR of7 to 6 breaths/minute is assigned an F value of +8 (high risk), and a RRof 6 to 5 breaths/minute is assigned an F value of +10 (higher risk).One potential reason as to why RR would decrease is owing to anincreased number of opioid molecules attached to opioid receptors in themidbrain. Opioids cause the RR to decrease from an average 15±3breaths/minute at rest. Opioids also cause the TV to decrease from anaverage 7 ml/kg at rest. Higher opioid receptor binding causes a moresevere and progressive decrease in the RR and TV over time. An opioidoverdose can occur quickly when a large amount of opioid reaches themidbrain opioid receptors quickly after a large oral dose or after anintravenous injection. In one example, the controller 26 may trigger analert, which may indicate caution as the absolute value of RR rate dropsto a first predetermined rate, or an alarm to trigger immediate actionwhen the RR drops below a second predetermined rate.

TABLE 1 Absolute RR in breaths/minute and the corresponding F value15-14 14-13 13-12 12-11 11-10 10-9 9-8 8-7 7-6 6-5 5-4 4-3 3-2 2-1 1-0 0−4 0 0 +1 +2 +3 +4 +5 +8 +10 +12 +16 +20 +30 +30 +30 Alert Alert AlertAlarm Alarm Alarm

In addition to the absolute RR discussed above and the resulting Fvalue, the controller 26 may further calculate the RR direction ofchange, symbolized by the up or down arrows in TABLE 2 below, and therate of change of the RR, and multiply those F values with weightingfactors. The controller 26 may automatically adjust the weighting factorover time in response the patient's previously analyzed RR trend data,to optimize the sensitivity and specificity for detecting and predictingthe progression from mild, to moderate, to severe hypoventilation. Forexample, the F value for RR may comprise three factors, namely, changein absolute RR, the direction of RR, and the rate of change of RR. Thedirection and rate of change of RR optionally may have a weightingfactor (W) on the score, for example, 2× or 3×, or any multiple. In oneexample,F_(RR)=(F_(absolute RR)+2F_(RR direction)+3F_(RR rate of change)). Anincreased number of opioid molecules attached to opioid receptors in themidbrain cause the RR to decrease from an average range of 15±3breaths/minute. Higher opioid receptor binding causes a progressivedecrease in the RR over time. An opioid overdose can occur quickly whena large amount of opioid reaches the midbrain receptors quickly after alarge oral dose, an intravenous injection, or combined with alcohol,benzodiazepams, or other respiratory depressant medications. This maycause the RR to become more variable with a slow or fast rate ofdecrease over a longer period of time. The ingestion of alcohol andother drugs may worsen the respiratory and cardiovascular affects whencombined with the opioids.

The RIS for opioid induced hypoventilation has a more positive value (+more risk) when there is a decrease in the RR over time. There is ahigher risk during a rapid decrease in RR over time. The RIS for opioidinduced hypoventilation has a more negative value (− less risk) whenthere is an increase in RR over time. There is a lower risk during arapid increase in RR over time. There is a non-linear increase in riskpoints when the RR decreases into the clinically significant range. Thecontroller 26 recognizes the vital sign pattern towards hypoventilationearly enough to prevent a permanent injury or death due to respiratoryacidosis and hypoxemia. The middle column of TABLE 2 may be used foradult patients with average sensitivity to opioid induced respiratorydepression. The left column may be used for patients with lowsensitivity to opioid induced respiratory depression. The right columnmay be used for patients with high sensitivity to opioid inducedrespiratory depression.

TABLE 2 RR direction and rate of change and corresponding F values forthree different patient sensitives to opioid induced respirationdepression. Respiratory Rate (RR) Low Average High Direction and Rate ofSensitivity Sensitivity Sensitivity Change Points Points Points RapidDecrease RR ↓↓ +4 +6 +8 Alarm Slow Decrease RR ↓ +2 +3 +4 Alert NoChange RR → 0 0 0 Slow Increase RR ↑ −2 −3 −4 Rapid Increase RR ↑↑ −4 −6−8

EXAMPLES

-   1. RR that is rapidly decreasing (+4) from 9 to 8 breaths/minute    (+2) increases the risk index score+6-   2. RR that is rapidly decreasing (+4) from 8 to 7 breaths/minute    (+3) increases the risk index score+7-   3. RR that is slowly decreasing (+2) from 7 to 6 breaths/minute (+5)    increases the risk index score+7-   4. RR that is rapidly increasing (−4) from 6 to 7 breaths/minute    (+5) increases the risk index score+1-   5. RR that is slowly decreasing (+2) from 12 to 11 breaths/minute    (+1) increases the risk index score+3

In addition to scoring the patient's RR, the controller 26 furtheranalyzes the patient's TV in a similar manner to that of RR rate. Anincreased number of opioid molecules attached to opioid receptors in themidbrain cause the TV to decrease from an average range of 500±50ml/breath (˜7 ml/kg). Higher opioid receptor binding causes aprogressive decrease in the TV over time. Hypoventilation and hypoxiaowing to an opioid overdose can occur quickly when a large amount ofopioid reaches the midbrain opioid receptors quickly after a large oraldose or an intravenous injection. The majority of opioid overdoses occurmore slowly, over a one to two-hour period. The ingestion of alcohol andother drugs may worsen the respiratory and cardiovascular affects whencombined with the opioids. TABLE 3 below shows the absolute F values forchanges of TV of an example patient weighing 70 kg. The RIS for opioidinduced hypoventilation has a more positive value (+ more risk) when alower TV than normal is measured. The RIS for opioid inducedhypoventilation has a more negative value (− less risk) when a higher TVis measured. Note the non-linear increase in risk points when the TVdecreases into the clinically significant range. The algorithmsrecognize the vital sign pattern towards hypoventilation early enough toprevent a permanent injury or death due to respiratory acidosis andhypoxemia. The F values are merely exemplary and may change based on theweight, age, and opioid sensitivity of the patient.

TABLE 3 Absolute TV in ml/kg. change in TV over a defined period oftime, and the corresponding F value Tidal Volume (TV) Tidal Volume (TV)Change in TV (ml/kg) (ml) (ml/kg) F value 10 ml/Kg × 70 Kg 700 ml  10 to9.5 −10 9.5 ml/Kg 665 ml 9.5 to 9.0 −8 9.0 ml/kg 630 ml 9.0 to 8.5 −68.5 ml/kg 595 ml 8.5 to 8.0 −4 8.0 ml/kg 560 ml 8.0 to 7.5 −2 7.5 ml/kg525 ml 7.5 to 7.0 0 7.0 ml/kg 490 ml 7.0 to 6.5 0 6.5 ml/kg 455 ml 6.5to 6.0 +2 6.0 ml/kg 420 ml 6.0 to 5.5 +4 5.5 ml/kg 385 ml 5.5 to 5.0 +65.0 ml/kg 350 ml 5.0 to 4.5 +8 4.5 ml/kg 315 ml 4.5 to 4.0 +10 4.0 ml/kg280 ml 4.0 to 3.5 +12 3.5 ml/kg 245 ml 3.5 to 3.0 +14 3.0 ml/kg 210 ml3.0 to 2.5 +20 2.5 ml/kg 175 ml 2.5 to 2.0 +30 2.0 ml/kg 140 ml 2.0 to1.5 +30 1.5 ml/kg 105 ml 1.5 to 1.0 +30 1.0 ml/kg 70 ml 1.0 to 0.5 +300.5 ml/kg 35 ml 0.5 to 0   +30 0 ml/kg 0 ml 0 +30

In addition to the absolute TV discussed above and the resulting Fvalue, the controller 26 further calculates the TV direction of change,symbolized by the up or down arrows in TABLE 4 below, and the rate ofchange of the TV, with weighting factors. The controller 26 mayautomatically adjust the weighting factor over time in response thepatient's previously analyzed TV trend data, to optimize the sensitivityand specificity for detecting and predicting the progression from mild,to moderate, to severe hypoventilation. For example, the F value for TVmay comprise three factors, namely, absolute TV, direction of TV, andrate of change of TV. The direction and rate of change of TV optionallymay have a weighting factor (W) on the F value, for example, 2× or 3×,or any multiple. In one example,F_(TV)=(F_(absolute TV)+2F_(TV direction)+3F_(TV rate of change)).

The middle column below may be used for adult patients with averagesensitivity to opioid induced respiratory depression. The left columnmay be used for patients with low sensitivity to opioid inducedrespiratory depression. The right column may be used for patients withhigh sensitivity to opioid induced respiratory depression.

TABLE 4 TV direction and rate of change and corresponding F values forthree different sensitivities to opioid induced respiration depression.Tidal Volume (TV) Low Average High Direction and Rate of SensitivitySensitivity Sensitivity Change Points Points Points Rapid Decrease TV ↓↓+4 +6 +8 Alarm Slow Decrease TV ↓ +2 +3 +4 Alert No Change TV → 0 0 0Slow Increase TV ↑ −2 −3 −4 Rapid Increase TV ↑↑ −4 −6 −8

EXAMPLES: Points 1. TV that is slowly decreasing (+3) from 7 to 6.5ml/Kg (0) +3 2. TV that is rapidly decreasing (+6) from 6.5 to 6ml/Kg(+2) +8 3. TV that is rapidly decreasing (+6) from 5 to 4.5 ml/Kg(+8) +14 4. TV that is rapidly decreasing (+6) from 4.5 ml to +16 4.0mg/Kg (+10) 5. TV that is slowing increasing (−3) from 4.5 to 5 ml/Kg(+8) +5 6. TV that is slowly increasing (−3) from 7 to 7.5 ml/Kg (0) −37. TV that is rapidly increasing (−6) from 7 to 7.5 ml/Kg (0) −6 8. TVthat is not increasing/decreasing (0) around 7 ml/Kg (0) 0 9. TV that israpidly increasing (−6) from 7 to 7.5 ml/Kg (0) −6 10. TV that israpidly increasing (−6) from 8.5 to 9 ml/Kg (6) −12 11. TV that israpidly increasing (−6) from 9.5 to 10 ml/Kg −16 (10)

An increasing opioid concentration in the brain produces an increasinglevel of sedation. Ambulatory people develop a progressive decrease inthe amount of activity (body movement) due to an increasing level ofsedation. An increasing level of sedation also causes a change fromnormal coordinated body movement to uncoordinated body movement. Anincreasing level of sedation also causes a pattern of head nodding. Arapid increase in the concentration of brain opioid can produce a rapiddecrease in the amount of body movement, change from coordinated touncoordinated movement, onset of head nodding, and a change fromstanding or sitting to the supine, lateral, or prone position.

The accelerometer 32 and controller 26 monitor body activity, bodyposition, and body coordination as an estimate of sedation level. Thepattern of body activity level is continuously analyzed to detect andpredict the progression from mild to moderate to severe hypoventilationdue to an opioid overdose. The controller 26 analyzes the decrease inbody activity level, presence of head nodding, presence of uncoordinatedbody movement, and change from the standing or sitting position to thesupine, lateral, or prone position to calculate an RIS fordetecting/predicting opioid induced hypoventilation. For example, asshown in TABLE 5, the RIS for opioid induced hypoventilation has a morepositive value (+ more risk) when a decreased amount of body activity,presence of head nodding, presence of uncoordinated movement, and changefrom the standing or sitting position to the lateral, supine, or proneposition are detected. The RIS for opioid induced hypoventilation has amore negative value (− less risk) when an increased in amount of bodyactivity is measured. The RIS can be updated every 20-30 seconds.

TABLE 5 F values for body position. Body Position Points Lying Prone +8Alert Lying Lateral +4 Lying Supine +2 Sitting 0 Standing −4 Walking −6

In addition to the absolute body position discussed above and theresulting F value, the controller 26 and accelerometer 32 furthercalculates the body position/activity level direction of change,symbolized by the up or down arrows in TABLE 6 below, and the rate ofchange of the body position/activity level, with weighting factors. Thecontroller 26 may automatically adjust the weighting factor over time inresponse to the patient's previously analyzed body position trend data,to optimize the sensitivity and specificity for detecting and predictingthe progression from mild, to moderate, to severe hypoventilation. Forexample, the F value for body position/activity level may comprise threefactors, namely, body position, direction of body position/activity fromambulatory to stationary, and rate of change of body position/activity.The direction and rate of change of body position/activity may have aweighting factor on the F value, for example, 2× or 3×, or any multiple.In one example,F_(body position/activity)=(F_(absolute body position/activity level)+2F_(body position/activity direction)+3F_(body position/activity rate of change)).

TABLE 6 body position/activity, direction and rate of change andcorresponding F values for three different sensitivities to opioidinduced respiration depression. Body Activity (Amount of Movement) LowAverage High Direction Sensitivity Sensitivity Sensitivity and Rate ofChange Points Points Points Rapid Decrease in +4 +6 +8 Alarm Activity ↓↓Slow Decrease in +2 +3 +4 Alert Activity ↓ No Change in Activity → 0 0 0Slow Increase in Activity ↑ −2 −3 −4 Rapid Increase in −4 −6 −8 Activity↑↑ No Body Motion +15 +15 +15 Alarm Uncoordinated Body +4 +4 +4 AlertMotion Head Nodding +4 +4 +4 Alert

EXAMPLES: Points Rapid decrease in body activity (+6), no body motion+29 (+15), lying prone (+8) Rapid decrease in body activity (+6),uncoordinated motion +6 (+4), standing (−4) Rapid decrease in bodyactivity (+6), head nodding +10 (+4), sitting (0) Slow decrease in bodyactivity (+3), head nodding +3 (+4), standing (−4) Slow increase in bodyactivity (−3), walking (−6) −9 Rapid increase in body activity (−6),walking (−6) −12

An increasing opioid concentration in the brain produces an increasinglevel of sedation and relaxation of the upper airway muscles leading topartial and/or complete upper airway obstruction. An increasing level ofsedation causes a change from talking to light snoring, moderatesnoring, heavy snoring, and episodes of obstructive apnea (completeairway obstruction). The sound transducer 20, accelerometer 32, andcontroller 26 monitor the amount of upper airway obstruction (snoring)and the number and duration of apnea episodes. The controller 26analyzes the degree of snoring and duration of apnea to calculate theRIS for detecting/predicting opioid induced hypoventilation.

As shown in TABLE 7, the RIS for opioid induced hypoventilation has amore positive value (+ more risk) when an increase in snoring andnumber/duration of apnea episodes are measured. In addition to acharacteristic decrease in RR and TV, opioids cause an increase in thenumber of apnea episodes of short or long duration. The RIS for opioidinduced hypoventilation has a more negative value (− less risk) withnormal breathing and talking. The real-time RIS is updated every 20-30seconds. The controller 26 may recognize the vital sign pattern towardshypoventilation early enough to prevent a permanent injury or death dueto respiratory acidosis and hypoxemia.

TABLE 7 upper airway obstruction (snoring and apnea) and examplesincorporating increases and decreases in body motion, activity, anddirection Upper Airway Obstruction (Snoring and Apnea) Points Apnea > 20seconds +20 Apnea > 15 seconds +10 Heavy Snoring +8 Moderate Snoring +4Light Snoring +2 No Snoring 0 Talking −8

EXAMPLES: Points Rapid decrease activity (+6), head nodding (+4),lateral position +22 (+4), heavy snoring (+8) Rapid decrease activity(+6), prone position (+8), moderate +26 snoring (+4), apnea > 10 (+8) Nomotion (+15), lateral position (+4), heavy snoring (+8), +47 apnea > 20sec (+20) Slow decrease activity (+3), uncoordinated motion (+4),lateral +11 position (+4) No change activity (0), sitting (0), nosnoring (0), talking (−8) −8 Slow increase activity (−3), walking (−6),talking (−8) −17

Continuing to refer to FIG. 7, the F values for each of the abovemeasured and calculated physiological conditions are correlated againsta predetermined scoring system to determine if an alert (minor warning)or alarm (major warning) are generated. For example, the controller 26continually measures the physiological conditions of the mammal andcalculates a new RIS after a predetermined period of time, for example,five seconds to a minute. The above F values for RR, TV, AL, P, S, andBC are merely exemplary and may change over times based on the normalbaseline of the particular patient. Additionally, when the sum,multiplication, division, or subtraction, or other combination of the Fvalues for RR, TV, AL, P, S, BC are calculated (RIS_(T)), and comparedagainst a predetermined risk threshold, which may be a range or a value,the rate at which the (RIS_(T)) changes and/or the trend direction (upor down) may also trigger an alert or an alarm. For example, if theRIS_(T) is rapidly changing and/or trending in a direction away from thepredetermined risk threshold by a predetermined value, range, or otherthreshold, an alarm or an alert may be triggered. Thus, in oneconfiguration, in addition to trending and rate of change factoring intoeach individual RR, TV, AL, P, S, and BC F values, trending and rate ofchange of the calculated RIS_(T) is also contemplated by the algorithmto determine the risk of an adverse event. Moreover, the disclosurecontemplates that any one of the F values alone, or in combination withany of the other values of RR, AL, P, S, and BC may form the RIS. Forexample, correlating the measured sound from airflow through the tracheato TV alone against a predetermined range of TV ranges or threshold maydetect an adverse event.

Referring now to FIG. 8, in another method, the controller 26 isconfigured to predict the onset of heat exhaustion and/or heat strokein, for example, athletes or military personnel using the RIS discussedabove. The controller 26 may measure the patient's RR and or TV asdiscussed above with respect to the method shown in FIG. 7, includingthe absolute value change, direction, and rate of change of RR. Thecontroller 26 further measures the patient's temperature withtemperature sensor 34 and calculates the temperature trend and rate ofchange of the measured temperature similar to the methods discussedabove. In another words, the controller 26 assigns an F value to theabsolute measured temperature and an F score, which may be weighted tothe trend (higher or lower) of the measured temperature and the rate ofchange. The sum of these F values, and the F values from the patient'smeasured RR or TV, may be compared to a threshold, and when the RISexceeds or otherwise deviates from the threshold an alert or alarm issounded. For example, a soldier wearing heavy clothing and a backpack ona 20-mile march may develop an increased cellular metabolism, increasedCO2 production, dehydration, and increased body temperature.Compensatory mechanism may be exceeded during the march in somesoldiers, leading to a rapid rise in CO2 production, a rapid rise inlactic acid (metabolic acidosis), a rapid rise in minute ventilation,and a rapid rise in body temperature (heat exhaustion and/or heatstroke).

Referring to FIG. 9, another embodiment and application of the AVMS 27may be employed in fitness tracking and training. It is known thatrespiratory function is an indicator of physical fitness. The AVMS 27can be used to track RR, TV, and minute ventilation (MV) during mild,moderate, and heavy activity (exercise) of short or long duration. Thebody's response during the increased activity and during the recoveryperiod after the activity are an estimate of health and physicalfitness. These measured parameters may be paired to exercise or trainingtime spent at optimal range, maximum minute ventilation (measure ofexertion), and progress against goals among other potential analyticaland statistical outputs. In other words, the measured minuteventilation, RR, and TV may be compared to a goal of minute ventilation,RR, and TV during and after the activity to determine if fitness goalsare progressing. Heart rate trend measurements may be combined with MV,RR, TV, and body temperature trend measurements to enhance fitnessmonitor performance.

Referring now to FIG. 10, similar to the algorithm shown in FIG. 7, achange from stable lung function in ambulatory patients with chronicobstructive pulmonary disease (COPD) and asthma to unstable or worseninglung function during an acute exacerbation of COPD and/or asthma may bedetermined by comparing known RR and TV flow rates of a particularpatient or range of known values, against measured RR and TV flow rates.A RIS value that defines a clinically significant change in lungfunction may be assigned based on the percentage deviation from normaland the rate at which the deviation from the normal is increasing.Alarms or alerts may be generated when the RIS and the RIS trenddeviates from predetermined ranges.

Referring now to FIG. 11, in this configuration, the TSD 10 includes twointernal microphones 20, one external microphone for noise cancelling, areflectance pulse oximeter 36, a temperature sensor 34, ECG electrodes38, and an accelerometer 32. The TSD 10 is releasably coupled to acoupling component 40 adhered to the patient's skin with a surroundingarea of adhesive tape 30 to releasably connect the TSD 10 to thepatient. The coupling component 40 may be adhered to the skin of theneck with the adhesive tape 30 for up to 2 weeks, while the TSD 10 maybe removed every few days for recharging. In one configuration, thehousing 12 may include a first connector 42, for example, a flange,hook, locking ring or other connectors to releasably couple the housing12 to a corresponding second connector 44 of the coupling component 40.The adhesive tape 30 may at least partially surround the flexiblediaphragm 22 (similar to a pediatric stethoscope head) for attachment tothe skin surface of the neck. In one embodiment, the outer surface ofcoupling component's 40 flexible diaphragm 22 may be coated with anadhesive for robust attachment to the skin surface. Connecting the firstconnector 42 with the second connector 44 may form a single airtightunit that securely attaches to the skin of the neck above the trachealnotch or lateral to the larynx and excludes ambient sounds. The flexiblediaphragm 22 and the bell-shaped chamber may enhance the signal-to-noiseratio of the sound signal measured by the TSD microphones 20. In oneembodiment, the second connector 44 may be disposed around thecircumference of the diaphragm 22 with the adhesive 30 that mechanicallyattaches the diaphragm 22 surface to the skin surface. The adhesive tape30 may further be disposed around the circumference of the flexiblediaphragm 22 to firmly secure the coupling component 40 to the skinsurface. In another configuration, the center of the adhesive tape 30may include an open center area between the skin surface and the TSDmicrophones 20. The open configuration (without a diaphragm) and thebell-shaped stethoscope head may enhance the signal-to-noise ratio ofthe sound signal measured by the TSD microphone 20.

Although the above embodiments were discussed with respect to medicalapplications, it is further contemplated that any of the aboveembodiments may be used in non-medical settings. For example, the AVMS27 may be used by first responders, whether firefighters, police, EMS,or hazmat teams when encountering potentially dangerous gases,chemicals, or weapons of mass destruction that may affect breathing oracute upper airway obstruction. The AVMS 27 can detect hyperventilationor hypoventilation conditions of first responders which may identify thepresence of harmful and potentially dangerous gases or chemicals. Inanother embodiments, the AVMS 27 may be used to detect low O2 situationssuch as oil field, breweries, chemical manufacturing facilities, miningoperations, dry ice manufacture, food processing andrefrigeration/freezing facilities, as well as aviation hypoxia and highaltitude; astronauts, space capsules, space suits, etc.

It may be appreciated by persons skilled in the art that the presentembodiments are not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings.

What is claimed is:
 1. A method of monitoring respiration an acousticmeasurement device, the acoustic measurement device having a soundtransducer, the sound transducer configured to measure sound associatedwith airflow through a mammalian trachea, the method comprising:correlating the measured sound into a measurement of tidal volume;calculating an absolute tidal volume, a direction of tidal volume, and arate of change of tidal volume; assigning a risk index value to each ofthe absolute tidal volume, the direction of tidal volume, and the rateof change of tidal volume, each risk index value being one selected fromthe group consisting of a positive score and a negative score based on apredefined scale; calculating a sum of the risk index values assigned toeach of the absolute tidal volume, the direction of tidal volume, andthe rate of change of tidal volume; and generating at least one selectedfrom the group consisting of an alert and an alarm if the calculated sumexceeds a predetermined risk score threshold.
 2. The method of claim 1,wherein the measurement of sound associated with airflow through thetrachea occurs periodically.
 3. The method of claim 1, wherein theacoustic measurement device includes a housing, and wherein the soundtransducer is suspended within the housing.
 4. The method of claim 3,wherein the housing of the acoustic measurement device has a widthbetween 0.5 cm and 2.5 cm.
 5. The method of claim 3, wherein the housingdefines an opening, and wherein the sound transducer is disposed on anend of the housing opposite the opening.
 6. The method of claim 3,wherein the housing is configured to releasably couple to skin of themammalian trachea.
 7. The method of claim 6, wherein the housingincludes a diaphragm configured to vibrate in response to sound.
 8. Themethod of claim 7, wherein the housing is configured to engage acoupling component releasably adhered to the skin, and wherein thecoupling component includes the diaphragm.
 9. The method of claim 8,wherein the housing includes a connector configured to engage thecoupling component.
 10. The method of claim 1, wherein the acousticmeasurement device further includes an accelerometer configured tomeasure a relative body position and a movement of the mammal, andwherein the method further includes modifying the respectivepredetermined range based on the mammal's relative position andmovement.
 11. The method of claim 1, wherein the acoustic measurementdevice further includes at least one from the group consisting of adevice configured to measure a cardiac electrogram, temperature, andblood oxygenation.
 12. The method of claim 1, further includingfiltering out ambient noise from the measured sound.